Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-S008 | Other Identifier | Eli Lilly and Company |
Not provided
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Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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There will be 2 phases in this study. Patients will either be enrolled to the first phase or to the second phase, depending upon when they enroll into the study.
The first phase of this study is done to evaluate the safety of enzastaurin in patients. This is done by gradually increasing the dose of the drug in small groups of patients and watching closely for side effects.
In the second phase of the study, the dose determined to be safe will be used with temozolomide during and following radiation therapy to see if the combination can help patients with brain tumors live longer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | The Phase 1 consisted of the dose escalation of enzastaurin in 2 cohorts of up to 6 patients to assess maximum tolerated dose (MTD). Cohort 1 = radiotherapy/enzastaurin 250 mg per day/temozolomide 75 mg/m^2 therapy. The 6 initial cohort patients were clinically evaluated for dose-limiting toxicities (DLT). If no more than 1 of 6 patients experienced a DLT or tumor progression, patients continued 1 complete adjuvant enzastaurin/temozolomide 28-day cycle. If there was no significant toxicity after the first adjuvant cycle, participants received subsequent adjuvant enzastaurin/temozolomide cycles. If no more than 1 of the 6 initial cohort participants treated at 250 mg of enzastaurin experienced a DLT during radiotherapy and the first adjuvant cycle, up to 6 more participants could be entered at 500 mg of enzastaurin. The Phase 2, using the MTD determined in the Phase 1 (250 mg), evaluated the combination's safety and measured OS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzastaurin | Drug | Phase 1 - 250 mg Cohort 1 with one dose escalation allowed to 500 mg for Cohort 2, oral, daily, 6 weeks then twelve 28 day cycles Phase 2 - Phase 1 established dose, oral, daily, 6 weeks then twelve 28 day cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1- Determination of the Maximum Tolerated Dose (MTD) of Enzastaurin | Phase 1- dose escalation of enzastaurin in 2 cohorts up to 6 participants each in order to assess MTD. After radiation/enzastaurin 250 mg per day/temozolomide 75 mg/m^2 therapy, if no more than 1 of 6 patients experienced a dose-limiting toxicity (DLT) or tumor progression, participants completed one 28-day cycle. If no significant toxicity after the first cycle, participants received subsequent cycles. If no more than 1 of the 6 patients treated at 250 mg of enzastaurin experienced a DLT, up to 6 more patients could be entered at escalated dose cohort of enzastaurin (500 mg). | Until MTD can be determined (up to 12 cycles, 28 days per cycle) |
| Phase 1 and Phase 2 - Overall Survival (OS) | OS is the time from surgical diagnosis to the date of death from any cause. For participants who were alive, OS was censored at the last contact. | Baseline to death from any cause (Up to 48 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 - Number of Participants With Adverse Events (AEs) | Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. | Every cycle (up to 12 cycles, 28 days per cycle) |
| Phase 1 and 2: Association Between Biomarkers and Clinical Outcome |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | San Francisco | California |
A total of 12 participants entered Phase 1 of the study. A total of 60 participants were analyzed in Phase 2 for a total of 72 participants for both phases.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1- Cohort 1 (250 mg Enzastaurin) | Phase 1--Determination of the maximum tolerated dose (MTD) of enzastaurin in participants with newly diagnosed GBM or GS receiving a 250 mg dose - Cohort 1. |
| FG001 | Phase 1 Cohort 2 (500 mg Enzastaurin) | Phase 1--Determination of the maximum tolerated dose (MTD) of enzastaurin in participants with newly diagnosed GBM or GS receiving a 500 mg dose - Cohort 2. |
| FG002 | Phase 2 | Phase 1 established dose (250 mg), daily for 6 weeks, then twelve 28-day cycles. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1- Cohort 1 (250 mg Enzastaurin) | Participants who received 250 mg enzastaurin in Phase I with 75 mg/m^2 temozolomide and radiotherapy. |
| BG001 | Phase 1 Cohort 2 (500 mg Enzastaurin ) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1- Determination of the Maximum Tolerated Dose (MTD) of Enzastaurin | Phase 1- dose escalation of enzastaurin in 2 cohorts up to 6 participants each in order to assess MTD. After radiation/enzastaurin 250 mg per day/temozolomide 75 mg/m^2 therapy, if no more than 1 of 6 patients experienced a dose-limiting toxicity (DLT) or tumor progression, participants completed one 28-day cycle. If no significant toxicity after the first cycle, participants received subsequent cycles. If no more than 1 of the 6 patients treated at 250 mg of enzastaurin experienced a DLT, up to 6 more patients could be entered at escalated dose cohort of enzastaurin (500 mg). | All Phase I participants who received at least one dose of study drug. | Posted | Number | milligrams (mg) | Until MTD can be determined (up to 12 cycles, 28 days per cycle) |
|
Not provided
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1- Cohort 1 (250 mg Enzastaurin) | Phase 1--Determination of the maximum tolerated dose (MTD) of enzastaurin in participants with newly diagnosed GBM or GS receiving a 250 mg dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA v12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
Not provided
Not provided
| ID | Term |
|---|---|
| C504878 | enzastaurin |
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| temozolomide | Drug | 75 milligrams per meter squared (mg/m^2), oral, daily, 6 weeks then 200 mg/m^2, oral, daily, twelve 28 day cycles |
|
| radiation therapy | Radiation | 1.8-2.0 Gy x 30 fractions, 5 days/week, for 6 weeks |
|
Phosphorylated-S6 (pS6) ribosomal protein is a biomarker that's being investigated as a potential marker for clinical outcome using 2211 or 2215 antibody to pS6. Reported here are the hazard ratios and 95% confidence intervals (CIs) for participants for whom an pS6 immunohistochemistry (IHC) score was available. The IHC assays were scored using a 0 to +3 scoring system (no positive staining was scored 0; at least 25% immunoreactivity of cells was scored +1; 26% to 75% was scored +2; and 76% or greater was scored +3). Hazard ratio (HR) > 1 indicates worse outcome for that IHC score. |
| Baseline, Cycle 2, end of study (up to 12 cycles, 28 days per cycle) |
| Phase 1 - Response Rate With Macdonald Criteria | Response categories: complete response (CR): disappearance of all enhancing tumor on consecutive magnetic resonance imaging (MRI) scans at least 1 month apart, off steroids, and neurologically stable or improved. Partial response (PR): 50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved. Progressive disease (PD): >25% increase in size of enhancing tumor or any new tumor on MRI scans, or neurologically worse, and steroids stable or increased. Stable disease (SD): all other situations. | Baseline, following radiation, every other cycle (up to 12 cycles, 28 days per cycle) |
| Phase 2 - Number of Participants With Adverse Events (AEs) | Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. | Every cycle (28 days per cycle) |
| Number of Participants Undergoing Magnetic Resonance Imaging/Magnetic Resonance Spectroscopy (MRI/MRS) for Clinical Evaluation at Baseline | Number of patients having MRI/MRS for clinical evaluation with baseline assessment. | Each radiologic assessment (up to 12 cycles, 28 days per cycle) |
| Phase 1 and 2 - Progression-Free Survival (PFS) | PFS was defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. | Baseline to measured progressive disease (up to 12 cycles, 28 days per cycle) |
| Functional Assessment of Cancer Therapy - Brain (FACT-Br) | Total FACT-Br score includes physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns related to brain tumors. The score ranges 0 to 200, with a higher score representing better quality of life. | Every cycle (up to 12 cycles, 28 days per cycle) |
| M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) | General and brain tumor-specific symptoms each assessed on a scale of 0 to 10, with a higher score representing higher symptom burden. The 4 symptom scales reported as changing over the course of the study are listed here. | Every cycle (up to 12 cycles, 28 days per cycle) |
| Phase 1- Pharmacokinetics (PK): Maximum Observed Drug Concentration During 1 Dosing Interval at Steady State (Cmax,ss) for Enzastaurin, LY326020, and Total Analyte (Enzastaurin + LY326020) When Enzastaurin Administered With or Without Temozolomide | Cmax,ss was calculated using concentration versus time data of enzastaurin, LY326020, and Total Analyte (enzastaurin + LY326020) when 250 mg or 500 mg enzastaurin was administered alone or with 75 mg/m^2 temozolomide. Data are reported as Geometric Mean and Geometric Coefficient of Variation (%). | Cycle 1 Day 22, Cycle 2 Day 5, 28 days per Cycle |
| Phase 1 and 2- Pharmacokinetics: Area Under the Concentration-Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) for Enzastaurin, LY326020 and Total Analyte (Enzastaurin + LY326020) When Enzastaurin Administered With or Without Temozolomide | AUCτ,ss was calculated using concentration versus time data of enzastaurin, LY326020, and total analyte (enzastaurin + LY326020). Data are reported as Geometric Mean and Geometric Coefficient of Variation (%). | Phase 1, Cycle 1 Day 22, Cycle 2 Day 5 of a 28 day Cycle; Phase 2, Cycle 1 Day 22 of a 28 day Cycle |
| United States |
| Treatment completed per protocol |
|
| other complicating disease |
|
| Disease Progression |
|
| mistaken thrombocytopenia |
|
| decline related hyponatremia/tumor |
|
| Adverse Event |
|
Participants who received 500 mg enzastaurin in Phase I with 75 mg/m^2 temozolomide and radiotherapy.
| BG002 | Phase 2 | Participants who received 250 mg enzastaurin in Phase II with 75 mg/m^2 temozolomide and radiotherapy. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | Phase 1 and Phase 2 - Overall Survival (OS) | OS is the time from surgical diagnosis to the date of death from any cause. For participants who were alive, OS was censored at the last contact. | Phase 2 participants combined with Phase 1 cohort 1 participants who also received 250 mg enzastaurin. | Posted | Median | 95% Confidence Interval | months | Baseline to death from any cause (Up to 48 weeks) |
|
|
|
| Secondary | Phase 1 - Number of Participants With Adverse Events (AEs) | Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. | All Phase I participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Every cycle (up to 12 cycles, 28 days per cycle) |
|
|
|
| Secondary | Phase 1 and 2: Association Between Biomarkers and Clinical Outcome | Phosphorylated-S6 (pS6) ribosomal protein is a biomarker that's being investigated as a potential marker for clinical outcome using 2211 or 2215 antibody to pS6. Reported here are the hazard ratios and 95% confidence intervals (CIs) for participants for whom an pS6 immunohistochemistry (IHC) score was available. The IHC assays were scored using a 0 to +3 scoring system (no positive staining was scored 0; at least 25% immunoreactivity of cells was scored +1; 26% to 75% was scored +2; and 76% or greater was scored +3). Hazard ratio (HR) > 1 indicates worse outcome for that IHC score. | Combined Phases 1 and 2 populations for whom IHC scores were obtained. HR > 1 indicates poorer overall survival for that IHC score. | Posted | Number | 95% Confidence Interval | Hazard ratio | Baseline, Cycle 2, end of study (up to 12 cycles, 28 days per cycle) |
|
|
|
| Secondary | Phase 1 - Response Rate With Macdonald Criteria | Response categories: complete response (CR): disappearance of all enhancing tumor on consecutive magnetic resonance imaging (MRI) scans at least 1 month apart, off steroids, and neurologically stable or improved. Partial response (PR): 50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved. Progressive disease (PD): >25% increase in size of enhancing tumor or any new tumor on MRI scans, or neurologically worse, and steroids stable or increased. Stable disease (SD): all other situations. | Efficacy analysis in phase I was not conducted. Instead, participants who took 250mg in phase I were pooled with phase II participants and are presented in other outcome measures (2 and 8, respectively) in this record. Thus there were 0 participants for this measure. | Posted | Baseline, following radiation, every other cycle (up to 12 cycles, 28 days per cycle) |
|
|
| Secondary | Phase 2 - Number of Participants With Adverse Events (AEs) | Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. | All Phase 2 participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Every cycle (28 days per cycle) |
|
|
|
| Secondary | Number of Participants Undergoing Magnetic Resonance Imaging/Magnetic Resonance Spectroscopy (MRI/MRS) for Clinical Evaluation at Baseline | Number of patients having MRI/MRS for clinical evaluation with baseline assessment. | 35 patients underwent MRI and had baseline measurement. | Posted | Count of Participants | Participants | No | Each radiologic assessment (up to 12 cycles, 28 days per cycle) |
|
|
|
| Secondary | Phase 1 and 2 - Progression-Free Survival (PFS) | PFS was defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. | Phase 2 participants combined with Phase 1 cohort 1 participants who also received 250 mg enzastaurin. | Posted | Median | 95% Confidence Interval | months | Baseline to measured progressive disease (up to 12 cycles, 28 days per cycle) |
|
|
|
| Secondary | Functional Assessment of Cancer Therapy - Brain (FACT-Br) | Total FACT-Br score includes physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns related to brain tumors. The score ranges 0 to 200, with a higher score representing better quality of life. | All treated participants who received at least one dose of study drug in the 250 mg enzastaurin cohort from Phases 1 and 2 combined and who also provided FACT-Br data from at least 1 visit (N = 65). One participant lacked these data. | Posted | Mean | Standard Deviation | units on a scale | Every cycle (up to 12 cycles, 28 days per cycle) |
|
|
|
| Secondary | M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) | General and brain tumor-specific symptoms each assessed on a scale of 0 to 10, with a higher score representing higher symptom burden. The 4 symptom scales reported as changing over the course of the study are listed here. | Posted | Mean | Standard Deviation | units on a scale | Every cycle (up to 12 cycles, 28 days per cycle) |
|
|
|
| Secondary | Phase 1- Pharmacokinetics (PK): Maximum Observed Drug Concentration During 1 Dosing Interval at Steady State (Cmax,ss) for Enzastaurin, LY326020, and Total Analyte (Enzastaurin + LY326020) When Enzastaurin Administered With or Without Temozolomide | Cmax,ss was calculated using concentration versus time data of enzastaurin, LY326020, and Total Analyte (enzastaurin + LY326020) when 250 mg or 500 mg enzastaurin was administered alone or with 75 mg/m^2 temozolomide. Data are reported as Geometric Mean and Geometric Coefficient of Variation (%). | Pharmacokinetic analyses were conducted for individual participants who received at least one dose of study drug and had pharmacokinetic samples collected. One participant dose was reduced from 500 mg to 250 mg after Cycle 1 Day 1 so is included in the 250 mg dose group (N=7). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole per liter (nmol/L) | Cycle 1 Day 22, Cycle 2 Day 5, 28 days per Cycle |
|
|
|
| Secondary | Phase 1 and 2- Pharmacokinetics: Area Under the Concentration-Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) for Enzastaurin, LY326020 and Total Analyte (Enzastaurin + LY326020) When Enzastaurin Administered With or Without Temozolomide | AUCτ,ss was calculated using concentration versus time data of enzastaurin, LY326020, and total analyte (enzastaurin + LY326020). Data are reported as Geometric Mean and Geometric Coefficient of Variation (%). | Pharmacokinetic analyses were conducted for individual participants who received at least one dose of study drug and had pharmacokinetic samples collected. In Phase I, one participant dose was reduced from 500 mg to 250 mg after Cycle 1 Day 1 so was included in 250 mg dose group (N=7). | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol•h/L | Phase 1, Cycle 1 Day 22, Cycle 2 Day 5 of a 28 day Cycle; Phase 2, Cycle 1 Day 22 of a 28 day Cycle |
|
|
|
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | Phase 1 Cohort 2 (500 mg Enzastaurin) | Phase 1--Determination of the maximum tolerated dose (MTD) of enzastaurin in participants with newly diagnosed GBM or GS receiving a 500 mg dose. | 1 | 6 | 6 | 6 |
| EG002 | Phase 2 - 250 mg Enzastaurin | Participants received 250 mg enzastaurin daily for 6 weeks, then twelve 28-day cycles. | 22 | 60 | 60 | 60 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA v12.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Systemic leakage | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Complex partial seizure | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Muscular weakness | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Myelitis | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA v12.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA v12.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v12.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
|
| Auditory disorder | Ear and labyrinth disorders | MedDRA v12.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hearing loss | Ear and labyrinth disorders | MedDRA v12.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA v12.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA v12.1 | Systematic Assessment |
|
| Cushingoid | Endocrine disorders | MedDRA v12.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA v12.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA v12.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Anal hemorrhage | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Feces discolored | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Oral hemorrhage | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Calcinosis | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Edema | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Edema limbs | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Fever | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Flu-like illness | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Flu-like symptoms | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hyperbilirubinemia | Hepatobiliary disorders | MedDRA v12.1 | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Bladder infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Bone infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Creatinine increased | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Ear, nose and throat examination abnormal | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Hemoglobin | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Hemoglobin decreased | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| International normalized ratio | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Leukocyte count decreased | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Neutrophils | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Platelets decreased | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Proctoscopy abnormal | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Weight gain | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Weight loss | Investigations | MedDRA v12.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Buttock pain | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Joint disorder | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v12.1 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v12.1 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Central nervous system necrosis | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Neurologic disorder NOS | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Taste alteration | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA v12.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA v12.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v12.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v12.1 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA v12.1 | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | MedDRA v12.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA v12.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA v12.1 | Systematic Assessment |
|
| Urine discoloration | Renal and urinary disorders | MedDRA v12.1 | Systematic Assessment |
|
| Urogenital disorder | Renal and urinary disorders | MedDRA v12.1 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA v12.1 | Systematic Assessment |
|
| Reproductive tract disorder | Reproductive system and breast disorders | MedDRA v12.1 | Systematic Assessment |
|
| Uterine pain | Reproductive system and breast disorders | MedDRA v12.1 | Systematic Assessment |
|
| Vaginal hemorrhage | Reproductive system and breast disorders | MedDRA v12.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Hemorrhage nasal | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Pulmonary disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Voice alteration | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
| Phlebitis superficial | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
|
| Vascular disorder | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
|
Not provided
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| Title | Measurements |
|---|---|
|
| Cycle 2 |
|
| Cycle 3 |
|
| Cycle 4 |
|
| Cycle 5 |
|
| Cycle 6 |
|
| Cycle 7 |
|
| Cycle 8 |
|
| Cycle 9 |
|
| Cycle 10 |
|
| Cycle 11 |
|
| Cycle 12 |
|
| Radiation therapy visit |
|
| Cycle 1 |
|
| Cycle 2 |
|
| Cycle 3 |
|
| Cycle 4 |
|
| Cycle 5 |
|
| Cycle 6 |
|
| Cycle 7 |
|
| Cycle 8 |
|
| Cycle 9 |
|
| Cycle 10 |
|
| Cycle 11 |
|
| Cycle 12 |
|
| LY326020 |
|
| Total Analyte |
|
| LY326020 |
|
| Total Analyte |
|